MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS

Model Number	VTICM5_12.1
Medical Device Problem Codes	Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.1mm vticm5_12.1, -11.0/1.5/179 (sphere/cylinder/axis), implantable collamer lens into the patient's right eye (od) on (b)(6)2023.Lens was repositioned on (b)(6) 2023 but this did not resolve the lens rotation and low vault.The lens was replaced with a longer length spherical lens on (b)(6) 2023.This did not resolve the problem.Cause of the event is reported as patient related factor, lens too short cause rotation.Reportedly, patient states near vision not so clear.
Additional Manufacturer Narrative
A4 - unk.A5 - unk.A6 - unk.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Additional Manufacturer Narrative
H6: device code: 1494: this lens model is contraindicated for patients with an anterior chamber depth (acd) less than 3.0mm.Claim#: (b)(4).
Additional Manufacturer Narrative
H3: device evaluation lens was returned in vial in liquid.Visual inspection found no visible damage to lens.Dimensional inspection found the lens to be within specification.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17862013
• Report Number: 2023826-2023-04222
• Device Sequence Number: 12194889
• Product Code: QCB
• UDI-Device Identifier: 00840311304769
• UDI-Public: 00840311304769
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: VTICM5_12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 12/11/2023; 10/02/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 12/12/2023; 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female